Fexofenadine and Pseudoephedrine Tablets Recalled for Failed Dissolution
Dr. Reddy's Laboratories is recalling Fexofenadine HCl 60 mg and Pseudoephedrine HCl 120 mg extended-release tablets because they failed to meet dissolution specifications, which may affect how the medication works in the body.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: This is an FDA Class III recall with no reported illnesses or injuries. The hazard is a manufacturing defect (failed dissolution) that is theoretical in nature. There is no evidence of actual harm to consumers, and no serious safety threat is documented in the source text.
Plain-English summary
Dr. Reddy's Laboratories, Inc. is recalling Fexofenadine HCl 60 mg and Pseudoephedrine HCl 120 mg Extended Release Tablets USP, an over-the-counter allergy and congestion medication, due to failed dissolution specifications.
Lot #AC2103329A did not meet the required dissolution standards. When a tablet fails dissolution testing, it may not break down properly in the body, potentially affecting the delivery and effectiveness of the active ingredients.
The recalled product was distributed nationwide in the United States. Approximately 2,928 cartons of 30-tablet packages were affected, with NDC 43598-823-31. The product was manufactured in India and distributed by Dr. Reddy's Laboratories, Inc., Princeton, NJ.
Consumers with this product should stop using it and consult their pharmacy or healthcare provider. The medication should not be used until the issue is resolved.
The recalled product
- Product
- FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI (FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI)
- Brand
- FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI
- Manufacturer
- Dr. Reddy's Laboratories, Inc.
- Hazard
- dissolution-failure
- product-defect
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot #: AC2103329A
Distribution
Distributed nationwide across the United States.
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